Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Thursday, November 04, 2010

Richard Epstein, a professor at the New York University and University of Chicago law schools, just authored a report on the perils of conflict of interest rules. In his blog, "The Libertarian," he summarized his beliefs that strict conflict of interest (COI) rules and restrictions on pharmaceutical marketing "spell lower rates of innovation and slower dissemination of new products."

Prof Epstein is extremely prominent. The Manhattan Institute, of which he is a fellow, claimed, "Professor Epstein's influence is profound: he is one of the three most cited law professors in the United States and the most cited professor writing largely in private law." Thus, it is disturbing that it appears that his objections are based on a series of logical fallacies. (Note that we critiqued a defense of certain conflicts of interest he made in 2007 here on similar grounds.)

Ad Hominem: Enemies of Capitalism

Prof Epstein implied that the people who advocate strong conflict of interest rules are enemies of capitalism and free markets. For example, he wrote, "most of the modern critics of the drug and medical device industries start with the assumption that the profit-motive alone is sufficient to distort the behavior of all scientists and researchers." Later, "the people who line up most strongly against drug and device companies often treat the phrase 'market forces' as though it embodies the worst things in life." How he was able to read the minds of those who disagree with him is unclear. Attacking proponents of strict COI regulation as anti-capitalists (and by implication, socialists or communists) appears to be an ad hominem fallacy.

Burden of Proof: Ignoring Evidence of Harms of COI, Asserting Evidence of Benefits

Prof Epstein argued that COIs rarely if ever leads to bad effects: "the number of instances of serious abuses of power in the drug and device industry, like in medical research itself, is small, relative to the huge number of interactions that have taken place." Thus, he ignored evidence that commercially funded research may be biased in favor of the sponsors' products.(1-4) On the other hand, he implied that financial relationships among physicians and researchers and commercial firms that sell health care products and services are necessary for "rapid development and deployment of new pharmaceuticals and medical devices," and for "innovation" in the field, but provided no evidence for these points. Thus, while ignoring evidence of the possible harms of COIs, he failed to provide evidence for their benefits. By placing the burden of proof on those who disagree with him, while avoiding it himself, he invoked the burden of proof (or appeal to ignorance) fallacy.

Appeal to Common Practice: Scientists Wearing Multiple Hats

Prof Epstein asserted that strict COI rules would disturb what is now common practice. They would threaten how "the best research scientists in universities ... wear multiple hats. In addition to researching within the academy, they also offer consulting services to drug companies, or start businesses of their own." Academics may currently behave in this way, but that does not mean this behavior is optimal in any sense. Thus, Epstein employed the fallacy of the appeal to common practice.

Slippery Slope: Silencing Communication and Collaboration

Prof Epstein asserted that strict rules on COI would "prohibit the collaborative efforts that have long characterized standard practices [in research]." Specifically, he asserted the rules could stipulate that "no scientist who sits on any Food and Drug Administration (“FDA”) review committee, or any hospital conflict of interest committee, should be allowed to have connections with the pharmaceutical industry." Also, "collaborations between government and industry scientists on research projects of common interests should either be totally eliminated or heavily regulated." Finally, he asserted, "free interchange of information within and across firm boundaries is best calculated to allow the sharing and coordination of vital information," but "strong conflict of interest regulation poses real threats to these dynamic interactions."

Yet rules about conflicts of interest generally refer to those generated by financial relationships, most often payments by commercial firms to academics, researchers or physicians. Payments are not necessary for collaboration. Researchers can communicate, share information, even work together without one party paying the other. Warning of such dire consequences of regulations that have nothing directly to do with communication or collaboration amount to the slippery slope fallacy.

Appeal to Authority: the "Most Gifted Members of the Academy"

Prof Epstein noted above that it was the best researchers who consult for commercial firms or start their own firms. Later, he stated, "the ablest scientists often have the most extensive outside practices." In complaining about rules that limit the pay of faculty members for services on boards of directors of for-profit health care companies, he asked, "why crimp the behavior of the most gifted members of the academy who can also make major contributions to industry?" Thus he seemed to agree with the arguments made by representatives of pharmaceutical and device companies that the doctors who they pay to speak, consult, or do research are the best and the brightest. However, there is considerable evidence (e.g., see posts here and here), that such "key opinion leaders" or "thought leaders" are chosen because of their sympathy to the companies and their products, and their malleability. In addition, there is evidence that medical schools now put more emphasis on ability to attract external funding than any other faculty characteristic in decisions about payment, promotion, and retention (see post here). Prof Epstein's invocation of the need to honor the best and the brightest appears to be a variant on the appeal to authority fallacy.

Summary

So here we have another example, by " one of the nation's most prolific legal thinkers, (according to the Manhattan Institute) of a defense of the prevalent conflicts of interest that affect academic physicians and clinical researchers. Like many previous such defenses, it seemed to be mainly based on logical fallacies.

Also, like many previous such defenses, it was made by someone with a history of his own financial relationships with health care corporations. To his credit, Prof Epstein did disclose, "over the years, I have worked extensively with various groups in the pharmaceutical industry, but have done no such work in the past few years." On the other hand, he did not disclose his previous relationships with eSapience, a company which once claimed it "shapes the debate on issues that intersect law, economics, and policy." (See post here.)

The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them. I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone who does not have such relationships.

By the way, Prof Epstein also complained about overly rigorous regulation of pharmaceutical marketing in the same blog post, but since this really seems to be a distinct topic, I will not discuss his arguments here.

As a former pharma manager, I agree that COI harms pharma productivity. At the very least, it tends to divert money from R&D to marketing of the product in which the conflicts held by senior pharma executives exist.

Further, there are certainly dishonest capitalists on the right, but it's the left that believes in moral relativity as a virtue if I remember my politics correctly.

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